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RECRUITING

NCT07005102

PHASE2/PHASE3

A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

Sponsor: AbbVie

View on ClinicalTrials.gov

Summary

Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity "when telisotuzumab adizutecan is given in combination with a fixed dose of osimertinib (Osi)or standard of care (Osi plus platinum/pemetrexed chemotherapy). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. Osi is a drug approved for the treatment of NSCLC. This study will be divided into two stages, in the first stage participants will receive increasing doses of telisotuzumab adizutecan with Osi. Participants will then be randomized into 4 groups called treatment arms where 3 groups will receive 1 of 3 doses of telisotuzumab adizutecan from from the dose escalation phase with Osi, or standard of care (Osi plus chemotherapy). In the second stage participants will receive the optimal dose of telisotuzumab adizutecan, from the previous stage, with Osi, or SOC. Approximately 854 adult participants with 1L estimated glomerular filtration rate (EGFR) mut (mutated) not sufficient quantity (NSq) NSCLC will be enrolled in the study in 200 sites worldwide. In Stage 1, during dose escalation participants will receive increasing intravenous (IV) doses of telisotuzumab adizutecan with oral Osi tablets. participants will receive 1 of 3 doses of telisotuzumab adizutecan with Osi, or standard of care (Osi plus chemotherapy). In stage 2 participants will receive the optimal dose of IV telisotuzumab adizutecanin with oral Osi tablet, or SOC. The study will run for a duration of approximately 76 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Official title: A Phase 2/3 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

854

Start Date

2025-08-03

Completion Date

2031-12

Last Updated

2026-04-03

Healthy Volunteers

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Interventions

DRUG

Standard of Care

DRUG

Telisotuzumab Adizutecan

Intravenous (IV)

DRUG

Osimertinib (Osi)

Oral

DRUG

Cisplatin

DRUG

Carboplatin

DRUG

Pemetrexed

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period and prior to dosing of study treatment on Cycle 1 Day 1. * Must consent to provide recently obtained formalin-fixed, paraffin-embedded (FFPE) tumor tissue (ideally collected during or after locally advanced or metastatic diagnosis) or archived tissue during screening for c-Met immunohistochemistry (IHC) testing and study stratification. c-Met IHC results are required prior to randomization. * Must have at least one non-irradiated measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If only one measurable lesion exists, it is acceptable to be used (as a target lesion) as long as it has not been previously irradiated and as long as it has not been biopsied within 14 days of the baseline tumor assessment scans. * Any toxicities from prior systemic anti-cancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Grade 1 or baseline level (except for alopecia \[any grade\] or Grade \<= 2 peripheral neuropathy). * Should not have any major, life-threatening conditions and life expectancy as determined by the investigator should be at least 3 months. * No prior estimated glomerular filtration rate (EGFR) tyrosine kinase inhibitor (TKI) in the locally advanced and/or metastatic setting (except for when it is allowed on study prior to C1D1). Participants treated with prior EGFR TKI in the adjuvant setting are allowed to enroll provided that \>= 126 months (since last dose of e.g., adjuvant osimertinib) have passed before Cycle 1, Day 1. * Diagnosis of histologically or cytologically confirmed metastatic/locally advanced non-squamous NSCLC with documented classical EGFR mutation (Exon 19 Del or Exon 21 L858R) either alone or in combination with other EGFR mutations as detected by an Food and Drug Administration (FDA)-approved or other validated test in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory (sites in the US) or an accredited Laboratory (sites outside of the US) in accordance with site standard of care. A copy of the test report documenting the EGFR mutation must be available in the participant records. Exclusion Criteria: * History of interstitial lung disease (ILD), pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan. * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis. * Participants has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation. * History of any malignancy other than disease under study except for 1. Malignancy treated with curative intent and with no known active disease present for 2 years before the first dose of study treatment and felt to be at low risk for recurrence by investigator. 2. Successfully treated nonmelanoma skin cancer. 3. Localized carcinoma in situ of the cervix. 4. Breast Cancer; lobular carcinoma in situ or ductal carcinoma in situ that is considered completely cured.

Locations (46)

Ironwood Cancer & Research Centers - Chandler II /ID# 275443

Chandler, Arizona, United States

USC Norris Comprehensive Cancer Center /ID# 275343

Los Angeles, California, United States

Usc Norris Oncology/Hematology Treatment Center /ID# 278673

Newport Beach, California, United States

University Colorado Cancer Center /ID# 275382

Aurora, Colorado, United States

Mid Florida Hematology And Oncology Center /ID# 275278

Orange City, Florida, United States

The Iowa Clinic /ID# 276020

West Des Moines, Iowa, United States

Nho - Revive Research Institute /ID# 276115

Lincoln, Nebraska, United States

Renown Regional Medical Center /ID# 276049

Reno, Nevada, United States

Texas Oncology - South Austin /ID# 276033

Austin, Texas, United States

The University of Texas MD Anderson Cancer Center /ID# 275107

Houston, Texas, United States

Texas Oncology - Palestine Cancer Center /ID# 276034

Palestine, Texas, United States

Virginia Cancer Specialists - Fairfax /ID# 275071

Fairfax, Virginia, United States

Liverpool Hospital /ID# 276304

Liverpool, New South Wales, Australia

The Queen Elizabeth Hospital /ID# 275719

Woodville, South Australia, Australia

Austin Health /ID# 275505

Heidelberg, Victoria, Australia

St John Of God Murdoch Hospital /ID# 275700

Murdoch, Western Australia, Australia

Jessa Ziekenhuis - Campus Virga Jesse /ID# 275585

Hasselt, Limburg, Belgium

Universitair Ziekenhuis Leuven /ID# 275586

Leuven, Vlaams-Brabant, Belgium

AZ-Delta. /ID# 275753

Roeselare, West-Vlaanderen, Belgium

The Ottawa Hospital - General Campus /ID# 275611

Ottawa, Ontario, Canada

The Chaim Sheba Medical Center /ID# 274541

Ramat Gan, Tel Aviv, Israel

Rambam Health Care Campus- Haifa /ID# 274542

Haifa, Israel

Rabin Medical Center. /ID# 274540

Petah Tikva, Israel

IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 274948

Rome, Roma, Italy

Yokohama Municipal Citizen's Hospital /ID# 275682

Yokohama, Kanagawa, Japan

Niigata University Medical & Dental Hospital /ID# 275685

Niigata, Niigata, Japan

Osaka Medical And Pharmaceutical University Hospital /ID# 275684

Takatsuki, Osaka, Japan

Juntendo University Hospital /ID# 276424

Bunkyo-ku, Tokyo, Japan

National Cancer Center Hospital /ID# 275678

Chuo-Ku, Tokyo, Japan

Unidade Local de Saude de Braga, EPE /ID# 275394

Braga, Portugal

Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 275387

Porto, Portugal

Hospital Cuf Porto /ID# 275395

Porto, Portugal

National Cancer Centre Singapore /ID# 275986

Singapore, Central Singapore, Singapore

National University Hospital /ID# 275988

Singapore, Singapore

Inje University Haeundae Paik Hospital /ID# 275388

Busan, Busan Gwang Yeogsi, South Korea

Chungbuk National University Hospital /ID# 275768

Cheongju-si, North Chungcheong, South Korea

Yonsei University Health System Severance Hospital /ID# 275384

Seoul, Seoul Teugbyeolsi, South Korea

Asan Medical Center /ID# 275600

Seoul, Seoul Teugbyeolsi, South Korea

Samsung Medical Center /ID# 278083

Seoul, Seoul Teugbyeolsi, South Korea

Hospital Clinic de Barcelona /ID# 275476

Barcelona, Spain

Hospital General Universitario Gregorio Maranon /ID# 275475

Madrid, Spain

Hospital Universitario 12 de Octubre /ID# 277698

Madrid, Spain

Instituto Valenciano de Oncología /ID# 275471

Valencia, Spain

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 275293

Kaohsiung City, Taiwan

National Taiwan University Cancer Center (Ntucc) /ID# 275291

Taipei, Taiwan

Taipei Veterans General Hospital- Taipei City /ID# 275292

Taipei, Taiwan

Clinical Research Directory

A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (46)